An interventional study of Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) and Usual Care Rehabilitation in Concussion, Mild, Mild Traumatic Brain Injury (mTBI) and Psychological Health, sponsored by University of Pittsburgh. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.
Nearly 378,000 mTBIs have occurred among U.S. military service members (SM) since 2000. These injuries result in myriad symptoms (e.g., dizziness, headache, fogginess) and impairments (e.g., cognitive, ocular, vestibular) that typically resolve within a month. However, many SMs experience symptoms and impairment lasting months or longer, resulting in limited operational readiness and duty restrictions. As such, one of the challenges related to mTBI and psychological health issues in military SMs is identifying and implementing timely and effective treatments that address these symptoms in an integrated manner and mitigate downstream problems.
Interventions are needed to target comorbid mTBI and psychological health symptoms. Previous research suggests that targeted rehabilitation combined with behavioral management (physical activity, sleep, nutrition, hydration) is effective in improving symptoms and associated functional impairment and reducing recovery time following mTBI. Acceptance and Commitment Therapy (ACT) is a trans-diagnostic cognitive-behavioral therapy based on incorporation of mindfulness and acceptance-based work into traditional behavior therapy. ACT is designed to improve psychological health, functioning, and well-being by improving psychological flexibility or the ability to remain present in the moment despite emotional distress.
There is separate evidence for the effectiveness of targeted rehabilitation combined with behavioral management interventions, and ACT in regard to enhancing recovery from mTBI and PH, respectively. However, researchers have yet to synergize these approaches to evaluate their effectiveness in military SMs following mTBI involving symptom domains in psychological health. Our overarching hypothesis is that a combined, brief (\<4 weeks) intervention involving both ACT and integrated usual care rehabilitation will reduce symptoms, impairment, and functional limitations, and accelerate return to activity among military SMs and civilians following mTBI compared to usual care rehabilitation (CONTROL). The investigators believe that the potential synergy of these combined interventions could provide a more efficient and effective treatment strategy that could mitigate downstream psychological health morbidity in the estimated 60-65% of SMs with impairment following mTBI.
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The ACT intervention group will receive Acceptance and Commitment Therapy (ACT) + usual care rehabilitation exercises and behavioral management during four weekly in person sessions along with daily at-home activities during the 4 week treatment period. The four ACT sessions will last 60 minutes each and will include: 1) values clarification and goal setting; 2) skills training in psychological flexibility including emotional acceptance, cognitive defusion, and present moment awareness; and 3) practice engaging these skills to overcome mental obstacles to values-driven goal attainment.
Behavioral: Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) · Behavioral: Usual Care Rehabilitation
The CONTROL group will receive standard of care evaluations and treatments involving a holistic multidisciplinary approach, but will exclude any ACT components. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular, rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions such as instruction regarding stress reduction. The usual care intervention will be coordinated by a primary treating clinician and additional specialty care providers as indicated by the participant's evaluation, individualized patient goals, and concomitant treatments.
Behavioral: Usual Care Rehabilitation
Participants will receive the ACT treatment. It is comprised of three processes: Open Up, Be Present, and Do What Matters. Each of these is further sub-divided, for a total of six core processes. These processes include, but are not limited to, present moment awareness, de-fusion, and committed action. This group will also receive targeted vestibular therapy and standardized behavioral management strategies (physical activity, sleep, hydration, and nutrition prescription). Participants will also receive usual care at the discretion of each site's treating providers.
Participants will receive usual care treatment at the discretion of each site's treating providers, excluding any components associated with ACT. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions.
Generalized Anxiety Disorder (GAD-7)
The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
Neurobehavioral Symptom Inventory (NSI)
The NSI is a 22-item symptoms scale in which participants rate the severity of symptoms on a 5-point scale (0=none, 1= mild, 2=moderate, 3=severe, 4=very severe) Scores range from 0 to 60. The NSI takes approximately 5-10 minutes to administer. NSI total score changes will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
Ohio State University TBI Identification short form (OSU TBI-ID)
The OSU TBI-ID is a standardized form that collects lifetime instances of brain injuries via a 3-5 minute structured interview. For each past reported instance of a brain injury, the form collects the mechanism of injury, the occurrence of loss of consciousness (yes/no), duration of loss of consciousness (\< 30 mins, 30min-24hr, \>30 min), became dazed or experienced a memory gap, and age at injury.
Time frame: Baseline
Dizziness Handicap Inventory (DHI)
The DHI is a 25-item self-report measure that examines dizziness-related handicap. Each item is categorized into one of three domains: functional, emotional, or physical. The DHI was developed with the help of patients who complained of dizziness and uses a three-item response scale (Yes, Sometimes, No) scored as 4/2/0, respectively. Score range: 0-100, with higher scores indicating worse dizziness.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
Concussion Clinical Profiles Screening (CP-Screen)
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Symptom Reporting at 4-weeks
The VOMS assesses impairment via patient-reported symptom provocation following each of the following items: 1) smooth pursuits; 2) horizontal and vertical saccades; 3) convergence; 4) horizontal and vertical ocular reflex (VOR); and 5) visual motion sensitivity (VMS). Patients rate their symptom severity in headache, dizziness, nausea, and fogginess compared to their immediate pre-assessment state on a scale of 0 (none) to 10 (severe) to determine if any VOMS item provokes the symptoms. Scores on any symptom of 2 or greater reflects a positive screening cut-off for vestibular or oculomotor impairment. Total symptom scores are recorded for each symptom. Scores will be compared between Baseline and 4-week visits
Time frame: Baseline, 4-week
Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Convergence Measurement at 4-Weeks
See Outcome 8 for description of VOMS test. Convergence is also assessed in the VOMS using objective measurement of the near point of convergence (NPC). It is averaged across 3 trials, and recorded in centimeters (cm). NPC values \>5 cm reflect a positive clinical screening. Scores will be compared between Baseline and 4-week visits
Time frame: Baseline, 4-week
Modified Balance Error Scoring System (mBESS) - Change from Baseline in Total Errors at 4-weeks
The mBESS measures postural stability and consists of three stances including feet side by side, a tandem stance, and a single-leg stance on the non-dominant leg. The three stances are performed for 20 seconds each on a firm surface. All stances are completed with eyes closed and with hands on the iliac crests. Errors include lifting hands off the iliac crests, opening the eyes, stepping, stumbling, falling, moving the hips more than 30 degrees of flexion or abduction, lifting the forefoot or heel, or remaining out of the testing position for more than 5 seconds. Each error equals 1 point, with higher scores indicating worse performance. For the current study, the modified BESS (mBESS) on the firm surface only will be used. Clinical cut-offs for mBESS suggest a total error of 9 or greater indicate clinical impairment in balance. The mBESS takes approximately 5-6 minutes to administer. mBESS scores will be analyzed at each timepoint and over time.
Time frame: Baseline, 4-week
Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 is a 9 item questionnaire that assesses the presence and severity of depression. Total score ranges from 1-27, with higher scores indicating higher level of depression. Scale is 0-4 (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). PHQ-9 total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
DSM-Cross Cutting Symptom Measure - Adult (DSM-CCSM-A)
The DSM-CCSM-A is a 23-item self-report measure designed to evaluate overall and co-occurring psychological health symptoms including depression, anger, mania, anxiety, somatic symptoms, sleep disturbance, psychosis, obsessive thoughts/behaviors, substance use, personality function, dissociation, cognition, and suicide. The DSM-CCSM-A is commonly used to track therapeutic response to interventions. All items except for the three suicide-related items are rated 0-none to 4-severe/almost daily. Items scored at 2 or greater indicate important levels of symptoms that require further assessment. Scores range from 0-88. Scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
PTSD Checklist (PCL-5)
The PCL-5 is a 20-item self-report questionnaire corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms. The items are rated on a 5-point Likert scale, 0-4 for each symptom, and summed for a total severity score ranging from 0-80. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0)
The WHODAS 2.0 Measures average functioning in everyday situations over the last 30 days, and surveys six domains of functioning (cognition, mobility, self-care, getting along with others, life activities and participation. The modified version will be used in this study. It contains 12 items rated on a 5-point scale 0-4, with summary score of 0-100 (where 0 = no disability; 100 = full disability). Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
Acceptance and Action Questionnaire - Version 2 (AAQ-II)
The AAQ-II is a 7-item self-report questionnaire with items rated on a 7-point Likert scale 1-7 (1=Never true to 7=Always true). It is used to measure an individual's behaviors regarding their ability to process feelings, emotions, and worries. It is often used to measure progress in Acceptance and Commitment Therapy. Higher total scores indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
Work and Social Adjustment Scale (WSAS)
The WSAS assesses the impact of a person's mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure and personal or family relationships. It is a 5-item self-report questionnaire on a 9-point Likert scale 0-8 (0=Not at all; 8=Very Severely). Higher scores indicate greater difficulty. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
Patient Global Impression of Change (PGIC)
The PGIC was developed for self-reported assessment of change resulting from post-concussion care at military treatment facilities. The prompt is: ""Since beginning treatment at this facility, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS and OVERALL QUALITY OF LIFE related to your post-concussive condition?"" The participant responds on a scale ranging from 0 (No change or condition has gotten worse), to 7 (A great deal better and a considerable improvement that has made all the difference). Lower scores indicate worse recovery. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: 4-week, 3-month, 6-month study visits
Return to Duty (RTD)/Return to Activity (RTA) Status
For civilians, return to activity (RTA) will be medical clearance to resume full activities without limitations based on symptom and impairment free at rest, and symptom free following standardized exertion protocols per recent consensus. Return to duty (RTD) will be determined based on: Not returned to duty/Returned to duty with restrictions/Returned to duty without restrictions.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
I-Portal Portable Assessment System (I-PAS) - Eye Movements
Description of test: The I-PAS is a portable, 3-D virtual reality (VR)-based, video-oculographic test device to evaluate vestibulo-ocular function. The goggles are placed on the head of participants who are then asked to follow the instructions on the VR display. A series of vestibulo-ocular tests are performed, and data is recorded via laptop interface. Participants will perform the following static and dynamic vestibular tests: spontaneous nystagmus, gaze nystagmus, positional, sinusoidal harmonic acceleration (SHA), SHA with visual enhancement and suppression; head impulse tests; as well as vestibulo-ocular and oculomotor tests including: smooth pursuits, vergence pursuit, vergence steps, predicted saccades, anti-saccades, visual vertical and horizontal, visual reaction time, and dual eye movement/motor tasks. The eye movements of each tested are recorded, and the changes in movement will be assessed from baseline to 4-week.
Time frame: Baseline, 4-week
I-Portal Portable Assessment System (I-PAS) - Symptoms
Please see description of I-PAS test in Outcome 19. Symptom severity will be rated 0 (none) to 10 (severe) for headache, nausea, dizziness, and fogginess before and after the I-PAS testing procedures. The totals will be compared from the beginning of the test to after, as well as between visits.
Time frame: Baseline, 4-week
Fitbit Activity
At Baseline, the study team will provide all participants with a Fitbit Inspire 3 (or similar device depending on market availability) physical activity tracker to wear and sync with participant's cell phones for the duration of the 4-week intervention period. The activity monitoring will provide confirmatory evidence of compliance via real-time monitoring of physical activity and sleep behaviors. The study team will download the Fitbit data collected, such as (but not limited to) step counts, heart rate, sleep, and daily activity across each day of the 4-week intervention period from Fitabase.
Time frame: Daily, starting at Baseline and ending at 4-week
Fitbit Activity - Step Counts
See Outcome 22 for description of Fitbit Daily step counts will be recorded.
Time frame: Daily, starting at Baseline and ending at 4-week
Fitbit Activity - Heart Rate
See Outcome 22 for description of Fitbit Daily heart rate (HR) measured as beats per minute will be recorded. This will include daily average, hour average, and minute average.
Time frame: Daily, starting at Baseline and ending at 4-week
Fitbit Activity - Sleep
See Outcome 22 for description of Fitbit Daily sleep information will be recorded. For each day/night of sleep, the following will be recorded: 1)minutes asleep, 2) minutes after wakeup, 3) minutes to fall asleep, 4) minutes of time in bed.
Time frame: Daily, starting at Baseline and ending at 4-week
Fitbit Activity - Daily Activity
See Outcome 22 for description of Fitbit Daily activity information will be recorded. For each day of activity, the following is recorded: 1)distance walked (miles), 2) time of activity (minutes), 3) calories burned
Time frame: Daily, starting at Baseline and ending at 4-week
Pain, Enjoyment of Life, and General Activity Scale (PEG)
The PEG includes 3 items assessing pain intensity and functional interference with enjoyment of life and general activity. It is scored by averaging the items; scores range from 0-10, with higher scores indicating higher pain intensity. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Time frame: Baseline, 4-week, 3-month, 6-month study visits
Plan to share: Yes — Per DoD grant requirement, de-identified data will be shared with the Federal Interagency Traumatic Brian Injury Research (FITBIR) informatics system and Congressionally Directed Medical Research Programs (CDMRP). This data includes non-identifiable demographic data, medical history, medications, and both primary and secondary outcomes (except I-PAS and Fitbit data).
Time frame: De-identified data will be shared with FITBIR on an annual basis as required by the funder (DoD). Data will be entered until the study has completed. All data will be available on the FITBIR website indefinitely.
Access criteria: Formal requests must be submitted and approved to FITBIR to access this study's de-identified data.
Data sharing details ↗ · fitbir.nih.gov
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